rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days

Drug: Rifaximin (XIFAXAN)

Rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days

Other Name: XIFAXAN

Placebo Comparator: sugar pill

Placebo 1 tablet three times a day for 14 days.

Drug: Placebo

Placebo 1 tablet three times a day for 14 days.

Detailed Description:

100 patients will be randomized into two groups.

Group A will receive one rifaximin 550 mg tablet three times a day (1650 mg/day) for 14 days, and after a 4-week washout period, receive one placebo tablet three times a day for 14 days.

Group B will receive placebo first, and then rifaximin with the same dosage schedule to Group A.

Assessments will be performed before application and 4 weeks after the last dosage, for both of rifaximin and placebo.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Males and females

> 18 years of age with rosacea defined as:

3-40 papules/pustules and < 2 nodules,

A score of 2-4 on the Investigator Global Assessment

Exclusion Criteria:

Untreated pancreatic insufficiency

Crohn's disease

Ulcerative colitis

Active celiac disease by clinical history

End stage renal failure

Less than 18 years old

Pregnancy or positive pregnancy test

Rosacea subtype 1 (no papules )

Topical or oral antibiotics within 4 weeks

Acne treatments within 4 weeks prior to randomization

Systemic retinoids within 90 days

Topical or systemic corticosteroids 4 weeks prior to randomization

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359228